Kornimate/medical-research-clean huggingface dataset:
pilot study for cell based therapies in patients with asthma

Conditions: Asthma; Allergic Rhinitis

Summary: the aim of this study is to investigate the immunomodulatory potential of isolated plasmacytoide dendritic cells (pdcs) and regulatory t-cells (tregs) isolated with clinical grade magnetic bead isolations techniques (macs®) on the antigen presenting cell-induced proliferation of lymphocytes after allergen uptake in an in vitro cell culture system.

pdcs as well as tregs will be co-incubated with generated allergen presenting cells, lymphocytes, and allergen. for in vitro experimentation immune cells will be collected from blood of grass mix or house dust mite sensitized atopic/asthmatic patients.

Eligibility criteria:
inclusion criteria: * male subjects suffering from allergic rhinitis and/or allergic asthma against timothy grass pollen (phleum pratense) and/or house dust mite. * age 18-60 years, * nonsmokers or smokers with a history of less than 1 pack years who have not smoked within the last 12 months. * positive skin prick test for timothy grass pollen (phleum pratense) and/or house dust mile within 12 months * able and willing to give written informed consent * hemoglobin ≥135 g/l * hematocrit ≥ 0,40 * body weight ≥ 50 kg and body mass index (bmi) within the range 19-32 kg/m² exclusion criteria: * history of lower respiratory tract infection and /or exacerbation of asthma within four weeks prior to the informed consent visit * febrile illness within four week before the trial examination * administration of oral, injectable, or dermal corticosteroids within the last 8 weeks or intranasal and/or inhaled corticosteroids within the last 4 weeks. * intake of methylxanthines, antihistamines, antileukotrienes, oral cromolyn sodium, or oral nedocromil sodium * past or present disease, which as judged by the investigator, may affect the outcome of this trial. these diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease, or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis). * specific immunotherapy (sit) within the last two years prior to screening * participation in another clinical trial 30 days prior to enrollment * donation of more than 500 ml of blood in the preceding 9 weeks before the trial-examination * hemoglobin below the normal lower limit * history of drug and/or alcohol abuse or dependence within 12 months of the trial * risk of non-compliance with trial procedures * suspected inability to understand the protocol requirements, instructions and trial-related restrictions, the nature, scope, and possible consequences of the trial * patient is tested human immunodeficiency virus (hiv)-1/2ab, hepatitis b surface antigen (hbsag), or hepatitis c virus antibodies (hcv-ab) positive
the effect of horizant (gabapentin enacarbil) on augmentation

Conditions: Restless Legs Syndrome

Summary: restless legs syndrome (rls) is a common neurological disorder. augmentation is the main complication during long-term da treatment of rls. this study aims to examine effect of horizant (gabapentin enacarbil) on augmentation in rls patients.

this is an open label single arm study. the purpose of the study is to demonstrate the efficacy of horizant in patients with rls who exhibit augmentation while on dopaminergic therapy. adult patients (age 18-85 years) with diagnosis of primary rls (diagnosed by study investigators) with augmentation on dopaminergic therapy will be screened for participation in the study. rls diagnosis will be made by the study investigators using international rls study group criteria. patients with augmentation on dopaminergic therapy as defined by nih 2007 with asrs of 5 to 15 will be offered to participate in the study. inclusion and exclusion criteria are listed below. the study will be performed after approval of the institutional review board of the university of missouri. a total of 50 subjects will be entered into the study over a period of 1 year. written consent will be obtained from all patients. after pre-participation evaluation for eligibility, subjects will be selected and enrolled in the study and followed for a total of 6 follow up visits (days 0, 30, 90, 120, 180, 360). subjects enrollment period will last up to 12 months. the total duration of study will be 24 months.

Eligibility criteria:
inclusion criteria: 1. adult patients with diagnosis of rls for more than one year. 2. patients who are on da therapy for 6 months or longer. 3. patients who developed augmentation (on stable dose of da) lasting for 3 months or longer. 4. augmentation severity rating scale of 5 to 15. 5. both males and females 6. age range = 18-85 year exclusion criteria: * known hypersensitivity to horizant or gabapentin products * peripheral neuropathy * radiculopathy * peripheral vascular disease * uremia \[abnormal blood urea nitrogen (bun) or creatinine on comprehensive metabolic panel (cmp)\] * anemia * patients who are currently pregnant * patients who currently take opioids, lithium, anti-nausea medications (e.g. metoclopramide), dopaminergic antagonists (e.g. haloperidol), 1st generation antihistamines (e.g. diphenhydramine, pseudoephedrine), anti-psychotic medications and iron therapy. * subjects with impaired decision making capability.
feasibility/acceptability of a brief motivational intervention for frequent/high-intensity cannabis use

Conditions: Cannabis Use

Summary: the study aims to develop a novel brief motivational mobile health (mhealth) intervention for high-risk and high-intensity cannabis use for non-collegiate young adults. a total of 120 young adults (ages 18-29, not enrolled at or attending a 4-year college or university) will be randomized to receive a mhealth intervention with text messages for five weeks or to an online resource/program with psychoeducation information about cannabis. the mhealth intervention will focus on prompting the young adult to reflect on their journey with cannabis and to reflect on their personal goals and how cannabis is reflected in these goals. personalized feedback about their patterns of use, motivations, emotions, and social connections will be integrated throughout the program. participants will come back to the program each week to reflect on the prior week and reflect on goals for the upcoming week. all participants will complete a program satisfaction survey and complete follow-up assessments at 3- and 6-months post-program.


Eligibility criteria:
inclusion criteria: * 18-29 years old * reside in washington state * have valid email address * report using cannabis on 15 or more days in the past month, using 2 or more times a day (when use) in the past month, and/or using high thc concentration products in the past month (\>60% thc) * have a mobile phone and agree to receive text messages and has an internet browser * not attending or enrolled at a 4-year college or university. exclusion criteria: * females who are pregnant or trying to become pregnant * those who are in substance abuse treatment at screening * those attending or enrolled at a 4-year college or university.
estimate the relationship between oral microbiota and stroke

Conditions: Stroke; Microbial Disease

Summary: oral bacteria constitute the second largest population of the human microbiome. recent studies have identified their role in the development of systemic diseases, such as cardiovascular and cerebrovascular diseases. streptococcus mutans (sm) is considered the primary pathogen responsible for dental caries. furthermore, in cases of oral inflammatory diseases, sm has been found to invade the bloodstream and disseminate, leading to systemic diseases. against this backdrop, this study aims to investigate disparities in oral flora between stroke patients and healthy individuals by collecting saliva samples from both groups.

oral bacteria constitute the second largest population of the human microbiome. recent studies have identified their role in the development of systemic diseases, such as cardiovascular and cerebrovascular diseases. streptococcus mutans (sm) is considered the primary pathogen responsible for dental caries. furthermore, in cases of oral inflammatory diseases, sm has been found to invade the bloodstream and disseminate, leading to systemic diseases. against this backdrop, this study aims to investigate disparities in oral flora between stroke patients and healthy individuals by collecting saliva samples from both groups. the objective of this study is to offer novel insights into the association between oral health and cerebrovascular disease occurrence while establishing a foundation for future research.

Eligibility criteria:
inclusion criteria: * 1. microbleeding/damage or rupture of small blood vessels in the brain has been diagnosed within the past 365 days 2. have done nuclear magnetic examination and can provide nuclear magnetic results exclusion criteria: * have received antibiotic quality within the last three months

Keywords: cnm streptococcus mutans cerebal microbleeds cerebral hemorrhage cerebral ischemia cnm-positive streptococcus mutans
does pai reduce pain after tka among knee arthroplasty patients receiving acb & ipack?

Conditions: Total Knee Athroplasty

Summary: the goal of this clinical trial is to determine whether periarticular injection (pai) alongside adductor canal block (acb) and infiltration between the popliteal artery and capsule of the knee (ipack) block can decrease post-operative pain in patients undergoing primary total knee arthroplasty. the main question it aims to answer is: • is acb/ipack without pai as effective as acb/ipack with pai for tka patients? participants will be assigned to one of the following groups at random: * acb/pack with pai * acb/ipack with saline injection participants will also be asked to complete pre- and post-operative questionnaires.

kim et al (2019) have shown that addition of acb/ipack to pai improves analgesic outcomes (the nerve blocks reduced pain with ambulation and reduced opioid consumption). tka patients receiving pai + acb/ipack (along with a comprehensive multimodal analgesic program) had low pain scores with ambulation on pod1: 1.7 +/- 1.4 (mean +/- sd, nrs, 0-10 scale). the opioid consumption in the first 24 hours was 40.6 +/- 32.1 (mg oral morphine equivalents). it is not clear if the pai component is necessary, given the theoretically nearly complete analgesic effects of the acb/ipack block. additionally, anecdotal evidence indicates that some surgeons at hss routinely use the pai and some do not, without obvious large differences in analgesic outcomes. while there may be a 'belt and suspenders' advantage to using pai in addition to acb/ipack, it is not desirable to perform unnecessary procedures. in this study, we seek to compare the efficacy of acb/ipack with and without pai in tka patients.

Eligibility criteria:
inclusion criteria: * planned use of regional anesthesia * ability to follow the major components of the study protocol * english speaking (secondary outcomes include questionnaires validated in english only) exclusion criteria: * patients younger than 25 years old and older than 80 * non-english speaking * patients intending to receive general anesthesia * contraindication to nerve blocks or peri-articular injection * patients with an asa of iv or higher * renal insufficiency (esrd, hd, estimated creatinine clearance \< 30 ml/min) * patients with major prior ipsilateral open knee surgery * chronic gabapentin/pregabalin use (regular use for longer than 3 months) * chronic opioid use (taking opioids for longer than 3 months)

Keywords: tka pai acb ipack knee arthroplasty
recovery kinetics following a soccer training in middle-aged males

Conditions: Skeletal Muscle Damage

Summary: this study aims at investigating the recovery kinetics of skeletal muscle damage, neuromuscular fatigue and performance following a single soccer trainning session in middle aged males. the participants will perform a soccer training session \[a single training session including 60 minutes of warm up, soccer technical exercises and small-sided game\] and a cotrol trial (no intervention included, only daily measurements) in randomized, repeated measures, crossover design. assesesments related to skeletal muscle damage, performance and neuromuscular fatigue will be executed before the training session and daily for four consecutive days after training.

eleven male middle-aged participants will be included in this study. participants will be initially informed about the main goals of study as well as the associated risks and benefits and then will provide their signed consent form. at baseline, they will undergo assessment of their anthropometrics (body mass, height, bmi, whr), body compotition (using dxa), physical contition level (peak oxygen consumption, vo2peak), haemodynamic profile (diastolic and diastolic blood pressure) and daily dietary intake.thereafter, they will participate in two experimental trials (control trial and soccer trial) in a randomized, crossover, repeated measure design: 1) st (soccer trial): participants in this trial will perform a soccer training session (60 min) consisted of warm-up, technical exercises and small-sided game, ct (control trial): participants in this trial will only execute the evaluations daily in the dependent variables (they will not receive any intervention). before each trial, the participants will provide a resting blood sample (for the determination of white blood cells, granulocyte cells, monocyte cells, lymphocyte cells, hemeatocrit, hemoglobin, red blood cells and platelets, total antioxidant capacity, glutathione and creatine kinase activity) and undergo assessments of their delay onset muscle soreness (doms), maximal voluntary isometric contraction (mvic) of knee extensors and flexors (by isokinetic dynamometer), height and power of countermovement jump (cmj-using force platform), 10m and 30m sprint time (will be evaluated using light cells). a 7-day wash-out period will apllied between st and ct. the blood sample will be collected before and 24, 48 and 72 hours post-taining. also, the evaluation of doms, mvic, sprinting performance, power and jump height (by cmj) will be evaluated before and 24, 48, 72 and 96 hours post training.

Eligibility criteria:
inclusion criteria: * free of musculoskeletal injuries * no use of ergogenic supplements or medication * free of chronic diseases * age of 40-60 years exclusion criteria: * musculoskeletal injury * use of alcohol, caffeine and any type of ergogenic supplements or medication during the course of the study

Keywords: recovery soccer soccer training performance inflammation
evaluation of patients with blood disorders

Conditions: Hematologic Disease

Summary: the hematology service provides hematology consultations for patients at the clinical center and participates in the training of hematology fellows. patients with a broad range of hematologic disorders must be available in order for the senior staff of the service to maintain clinical expertise and to provide the breadth of experience necessary for the fellowship program. the purpose of this protocol is to meet these needs by allowing the hematology service to see patients with a spectrum of hematologic diseases not studied on existing research protocols at the nih. these patients will be evaluated over the course of several outpatient visits and returned to the care of their referring physicians.this study was developed to evaluate and possibly treat patients with blood disorders. the hematology service of the national institutes of health is responsible for the care of patients participating in research studies. in addition the hematology service also provides consultation for small groups of patients with blood disorders that have not been diagnosed or that may need special testing. this study will also provide doctors at the nih the opportunity to learn more about a wide range of blood disorders and conditions. patients participating in this study will be evaluated over the course of several outpatient visits and will continue to be cared for by their regular physician.

the hematology service provides hematology consultations for patients at the clinical center and participates in the training of hematology fellows. patients with a broad range of hematologic disorders must be available in order for the senior staff of the service to maintain clinical expertise and to provide the breadth of experience necessary for the fellowship program. the purpose of this protocol is to meet these needs by allowing the hematology service to see patients with a spectrum of hematologic diseases not studied on existing research protocols at the nih. these patients will be evaluated over the course of several outpatient visits and returned to the care of their referring physicians.

Eligibility criteria:
* inclusion criteria: the patient must have or be suspected of having a blood disorder. the patient must be clinically stable enough for outpatient evaluation. the patients must be referred from a physician outside the nih who will continue to provide the patient's primary medical care. exclusion criteria: inability of patient, parent or legal gaurdian to provide informed consent.

Keywords: consultation training referral fellowship program outpatient blood disorder
cost utility of radical surgery in ovarian cancer

Conditions: Ovarian Cancer

Summary: the purpose of this study is to investigate the medico-economic impact of adherence to inca (national cancer institute) guidelines in ovarian cancer surgery by assessment of outcome in cost per quality adjusted life years (qaly).

this is a prospective, multicenter, comparative and non-randomized study designed to investigate the medico-economic impact of adherence to inca guidelines in ovarian cancer surgery by assessment of outcome in cost per quality adjusted life years (qaly). a cost-utility study will be performed. it will primarily aim to assess the incremental cost-utility ratio (icur) at 3 years of the two treatment strategies of ovarian cancer surgery: adherence to inca quality indicators versus non-adherence to inca quality indicators. consecutive patients with stage iiic and iv ovarian, tubal, and primary peritoneal malignancies will be recruited in different health care institutions, including comprehensive cancer centers, university hospitals and private hospitals. evaluation of adherence to quality indicators will be assessed retrospectively (once patients have completed the treatment) by two independent experts. 200 patients will be included over a period of 2 years and will be followed for a 3 years period after treatment (every 4 months the first two years and then every 6 months).

Eligibility criteria:
inclusion criteria: * 1. woman with age ≥ 18 years. * 2. newly diagnosed ovarian, tubal or peritoneal malignancies. * 3. epithelial histology. * 4. stage iiic or iva with extrapelvic carcinomatosis according to figo classification 2014. * 5. patients undergoing primary surgery or neoadjuvant chemotherapy. * 6. performance status ≤ 2. * 7. patient affiliated to a social health insurance in france. * 8. patient information and informed consent form signed prior to any study specific procedures. exclusion criteria: * 1. benign or borderline tumors. * 2. patients with extra-abdominal disease, except for pleural effusion with positive cytology. * 3. other malignancy diagnosed in the previous 5 years except skin cancer (other than melanoma). * 4. any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure. * 5. patient who has forfeited his/her freedom by administrative or legal award or who is under guardianship.
tracking results of ablations to combat af registry generation 2

Conditions: Atrial Fibrillation

Summary: the primary objective of the trac-af registry is to capture real-world safety and effectiveness data on atricure devices used to conduct concomitant open heart and/or hybrid ablation, and management of the left atrial appendage concomitant to a cardiac ablation.

the trac-af registry is a proactive measure for atricure to remain informed about the safety and effectiveness of their ablation devices and associated procedures under real-world use conditions. the analysis of the data from the registry may be used for product development efforts, regulatory submissions, and publications.

Eligibility criteria:
inclusion criteria: 1. patient has been scheduled by physician(s) to undergo or has undergone cardiac ablation procedure(s) utilizing at least one atricure device. exception: participating registry sites that wish to compare atricure devices, and their associated procedures' safety and effectiveness, with other therapies for the management of cardiac diseases, can include patients who did not receive treatment with an atricure device, but were treated or will be treated for similar baseline disease state. 2. patient is willing to provide written informed consent, (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this registry), or authorization per institution and geographical requirements. exclusion criteria: 1. patient is enrolled in a concurrent trial that may impact the treatment offered by the registry devices. 2. patient with exclusion criteria required by local governance.
treatment intensity - apraxia of speech

Conditions: Aphasia; CVA; Apraxia of Speech

Summary: a growing neurorehabilitation literature suggests that intense treatment may be desired to maximize the effects of therapy following neurologic injury. this investigation is designed to facilitate the development of efficacious, clinically applicable treatment for acquired apraxia of speech by examining the effects of intensity of treatment (e.g., 9 hours per week vs. 3 hours per week, while holding total number of sessions constant) with a group of speakers who have chronic apraxia of speech and aphasia.

this research was designed to examine the effects of treatment intensity on outcomes associated with an established treatment for acquired apraxia of speech (aos). intensity in the form of dose frequency and total intervention duration was evaluated with sound production treatment (spt). the investigators examined the effects of intense dose frequency (nine, one-hour sessions per week) and traditional dose frequency (three, one hour sessions per week). total number of treatment sessions was held constant allowing for comparison of total intervention duration (27 sessions over 3 weeks versus 27 sessions over 9 weeks). a two-phase, group cross-over design was used. thirty-six participants with chronic aphasia and aos were recruited. twenty-four participants completed then entire study and were quasi-randomly assigned to one of two treatment groups - intense first or traditional first (12 per group). one group received spt applied with intense dose frequency (spt-i) followed by spt applied with traditional dose frequency (spt-t). the other group received the treatments in the reverse order (spt-t followed by spt-i). a two week no treatment interval separated the treatment phases. the outcomes of interest addressed changes in trained and untrained speech behaviors.

Eligibility criteria:
inclusion criteria: * veterans and non veterans * males or females * stroke survivor who is at least 4 months post-stroke * speaker of english since childhood * ability to pass a pure-tone hearing screening (aided or unaided) * currently non-hospitalized * age 21 to 90 years exclusion criteria: * neurological condition other than stroke * currently clinically depressed * history of speech/language problems prior to stroke * untreated psychopathology

Keywords: apraxia aphasia rehabilitation efficacy intensity